Biodegradable polymer-coated thin strut sirolimus- -eluting stent versus durable polymer-coated everolimus-eluting stent in the diabetic population.

BACKGROUND: The number of patients with diabetes mellitus (DM) presenting with coronary artery disease is increasing and accounts for more than 30% of patients undergoing percutaneous coronary interventions (PCI). The biodegradable polymer drug-eluting stents were developed to improve vascular healing. It was sought herein, to determine 1-year clinical follow-up in patients with DM treated with the thin strut biodegradable polymer-coated sirolimus-eluting stent (BP-SES) versus durable coating everolimus-eluting stent (DP-EES). METHODS: Patients were retrospectively analyzed with DM were treated with either a BP-SES (ALEX™, Balton, Poland, n = 670) or a DP-EES (XIENCE™, Abbott, USA, n = 884) with available 1 year clinical follow-up using propensity score matching. Outcomes included target vessel revascularization (TVR) as efficacy outcome and all-cause death, myocardial infarction, and definite/probable stent thrombosis as safety outcomes. RESULTS: After propensity score matching 527 patients treated with BP-SES and 527 patients treated with DP-EES were selected. Procedural and clinical characteristics were similar between both groups. In-hospital mortality was 3.23% in BP-SES vs. 2.09% in DP-EES group (p = 0.25). One-year followup demonstrated comparable efficacy outcome TVR (BP-SES 6.64% vs. DP-EES 5.88%; p = 0.611), as well as similar safety outcomes of all-cause death (BP-SES 10.06% vs. DP-EES 7.59%; p = 0.158), myocardial infarction (BP-SES 7.959% vs. DP-EES 6.83%; p = 0.813), and definite/probable stent thrombosis (BP-SES 1.14% vs. DP-EES 0.76%; p = 0.525). CONCLUSIONS: The thin-strut biodegradable polymer coated, sirolimus-eluting stent demonstrated comparable clinical outcomes at 1-year after implantation to DP-EES. These data support the relative safety and efficacy of BP-SES in diabetic patients undergoing PCI.

Short-term stent coverage of second-generation zotarolimus-eluting durable polymer stents: Onyx one-month optical coherence tomography study.

INTRODUCTION: To date the early strut coverage with the second-generation durable-polymer ONYX zotarolimus-eluting stent (O-ZES) is unknown. AIM: Optical coherence tomography (OCT) assessed the strut coverage of O-ZES at thirty-day follow-up. MATERIAL AND METHODS: OCT was performed after implantation and at 1-month follow-up in 15 patients treated with O-ZES. RESULTS: Mean patient age was 67 ±7 years (73% males). The clinical presentation consisted of acute coronary syndromes (n = 13) and stable coronary disease (n = 2). Four (26%) patients had diabetes. OCT analysis was performed at baseline and 1-month follow-up in all stents. 378 cross-sections with 3582 struts were assessed at baseline and 3661 at follow-up. At follow-up, 88% struts were covered by tissue with a median thickness 37.91 µm (IQR: 22.32-64.15). Median in-stent area obstruction by neointima was 2.64% (IQR: 1.70-4.84). From the total stent covered area, 92.3% showed complete strut coverage. Homogeneous tissue was observed in 74% of cases. There were no differences in minimal lumen area (5.07 ±1.08 mm2 vs. 4.81 ±0.94 mm2, p = 0.125) or minimal stent area (4.95 ±1.22 mm2 vs. 4.92 ±0.99 mm2) at baseline and at follow-up. There were no differences in the rate of strut malapposition (4.3% vs. 5.7%, p = 0.417). For all stents, malapposition volume was 47.9 mm3 at baseline and 51.7 mm3 at follow-up, giving the late acquired stent malapposition volume of 3.8 mm3. CONCLUSIONS: The second-generation durable polymer O-ZES showed favorable vessel healing at 30-day OCT follow-up.

Safety and efficacy of biodegradable polymer-coated thin strut sirolimus-eluting stent vs. durable polymer-coated everolimus-eluting stent in patients with acute myocardial infarction.

INTRODUCTION: The biodegradable polymer drug-eluting stents were developed to improve vascular healing. However, further data are needed to confirm the safety and efficacy of these stents in patients with acute myocardial infarction (AMI). AIM: We sought to determine the 1-year clinical follow-up in patients with AMI treated with a thin strut biodegradable polymer-coated sirolimus-eluting stent (BP-SES) versus a durable coating everolimus-eluting stent (DP-EES). MATERIAL AND METHODS: We analyzed patients with AMI (STEMI and NSTEMI) treated with either a BP-SES (ALEX, Balton, Poland, n = 886) or DP-EES (XIENCE, Abbott, USA, n = 1054) with available 1-year clinical follow-up using propensity score matching. Outcomes included target vessel revascularization (TVR) as the efficacy outcome and all-cause death, myocardial infarction, and definite/probable stent thrombosis as safety outcomes. RESULTS: After propensity score matching 672 patients treated with BP-SES and 672 patients treated with DP-EES were selected. Procedural and clinical characteristics were similar between the groups. In-hospital mortality was similar in both tested groups. One-year follow-up demonstrated comparable efficacy outcome TVR (BP-SES 7.1% vs. DP-EES 5.2%, p = 0.14), as well as similar safety outcomes of all-cause death, myocardial infarction, and definite/probable stent thrombosis. CONCLUSIONS: The thin-strut biodegradable polymer coated sirolimus-eluting stent demonstrated comparable clinical outcomes at 1 year after implantation to the DP-EES. These data support the relative safety and efficacy of BP-SES in AMI patients undergoing percutaneous coronary intervention.